Perioperative Chemotherapy for Potentially Resectable Gastric Cancer

Phase 2

Completed

• Conditions: Gastric Cancer
• Interventions: Drug: Oxaliplatin; Capecitabine; Drug: Tegafur, Gimeracil and Oteracil Potassium Capsules；Oxaliplatin

• Registration Number: NCT01516944
• Lead Sponsor: Hebei Medical University

Brief Summary

Stage I：Neoadjuvant therapy

* Tegafur，Gimeracil and Oteracil Potassium Capsules plus oxaliplatin is superior to surgery alone;Capecitabine plus oxaliplatin is non-inferiority to Tegafur，Gimeracil and Oteracil Potassium Capsules plus oxaliplatin

Stage II: Perioperative therapy

* Perioperative Tegafur，Gimeracil and Oteracil Potassium Capsules plus oxaliplatin is superior to adjuvant Tegafur，Gimeracil and Oteracil Potassium Capsules plus oxaliplatin alone;Capecitabine plus oxaliplatin regimen is noninferiority to Tegafur,Gimeracil and Oteracil Potassium Capsules plus oxaliplatin

* A regimen of Tegafur，Gimeracil and Oteracil Potassium Capsules plus oxaliplatin(SOX) and Capecitabine plus oxaliplatin(XELOX) improves survival among patients with incurable locally advanced or metastatic gastric cancer. The investigators assessed whether the addition of a perioperative regimen of SOX or XELOX regimen to adjuvant alone improves R0 resection rate and survival among patients with curable locally advanced gastric cancer.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-01-10
• Study First Submitted QC: 2012-01-24
• Study First Posted: 2012-01-25
• Study Start: 2012-02
• Primary Completion: 2018-04
• Study Completion: 2018-12
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-11
• Last Update Posted: 2020-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 749

Inclusion Criteria

• Age 18 -75
• Histologically or cytologically proven in operable advanced gastric adenocarcinoma (including adenocarcinoma of the gastrooesophageal junction)
• ECOG performance status ≦2
• Tumor stage T3/4NxM0
• No distant metastasis (M0)

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Exclusion Criteria

• History of hypersensitivity to fluoropyrimidines, Tegafur，Gimeracil and Oteracil Potassium Capsules , capecitabine, oxaliplatin or the ingredients of this product
• Inadequate hematopoietic function： WBC≦4,000/mm3; ANC≦2,000/mm3; Platelet≦100,000/mm3
• Inadequate organ function which is defined as below:

Total bilirubin >2 pper limit of normal range (ULN); ALT / AST > 2.5 upper limit of normal range (ULN) (>5.0 x ULN if hepatic metastasis); serum creatinine > 1.2 mg/dL, and Ccr > 60 ml/min (estimated by Cockcroft-Gault formulation);

• Symptomatic peripheral neuropathy
• Receiving a concomitant treatment with other fluoropyrimidines
• Pregnancy or lactation women, or women with suspected pregnancy or men unless using a reliable and appropriate contraceptive method.
• Mental status is not fit for chemotherapy therapy presence of serious concomitant illness which might be aggravated by study medication:
• Active cardiac disease e.g. decompensate myocardial infarction within the 6-month period preceding entry into the study.
• History of ventricular arrhythmia or congestive heart failure.
• Significant co-morbid medical conditions, including, but not limited to, Chronic obstructive pulmonary disease, interstitial pneumonia ,pulmonary fibrosis, heart failure, renal failure, hepatic failure, haemorrhagic peptic ulcer, mechanical or paralytic ileus, or poorly controlled diabetes.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Perioperative chemotherapy,XELOX	Oxaliplatin; Capecitabine	-
Perioperative chemotherapy,SOX	Tegafur, Gimeracil and Oteracil Potassium Capsules；Oxaliplatin	-
postoperative chemotherapy,SOX	Tegafur, Gimeracil and Oteracil Potassium Capsules；Oxaliplatin	-

Primary Outcome Measures

Name	Time	Method
Disease-free survival(DFS)	3 year

Secondary Outcome Measures

Name	Time	Method
Disease control rate (DCR)	At the end of the study	To Assess disease control rate (DCR) as defined CR + PR + SD assessed by RECIST criteria
Objective response rate (ORR)	At the end of the study
Down staging rate	Within 3 weeks after surgery	After the pathological examination of resected specimen
Overall survival (OS)	5 year
Adverse events	Side effects during observation	Investigators graded all adverse events and toxic effects according to the National Cancer Institute's Common Toxicity Criteria, version 2.0. The number of Participants with adverse events will be recorded at each treatment visit.
R0-resection rate	Within 3 weeks after surgery	After the pathological examination of resected specimen

Trial Locations

Locations (1)

Department of General Surgery; 🇨🇳 Shijiazhuang, Hebei, China